American Ginseng Extract in Preventing Respiratory Infection and in Reducing Antibiotic Use in Patients With CLL

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Wake Forest Cancer Center CCOP Research Base
ClinicalTrials.gov Identifier:
NCT00752895
First received: September 13, 2008
Last updated: April 3, 2013
Last verified: April 2013
  Purpose

RATIONALE: American ginseng extract may prevent or reduce acute respiratory illness in patients with chronic lymphocytic leukemia. It is not yet known whether American ginseng extract is more effective than a placebo in preventing respiratory infections.

PURPOSE: This randomized phase III trial is studying the side effects of American ginseng extract and to see how well it works compared with a placebo in preventing respiratory infection and in reducing antibiotic use in patients with chronic lymphocytic leukemia.


Condition Intervention Phase
Leukemia
Dietary Supplement: American ginseng
Dietary Supplement: placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Factorial Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: A Phase III Randomized, Double-Blind, Placebo Controlled Trial of North American Ginseng Extract (CVT-E002; COLD-fX®) to Prevent Respiratory Infection and Reduce Antibiotic Use in Patients With Chronic Lymphocytic Leukemia

Resource links provided by NLM:


Further study details as provided by Wake Forest Cancer Center CCOP Research Base:

Primary Outcome Measures:
  • Number of acute respiratory infection (ARI) days during a fixed 3-month period [ Time Frame: 3 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Number of antibiotic use days [ Time Frame: 3 months ] [ Designated as safety issue: No ]
  • Rate of all infections [ Time Frame: 3 months ] [ Designated as safety issue: No ]
  • Duration and severity of each ARI episode [ Time Frame: 3 months ] [ Designated as safety issue: No ]
  • Incidence of major infections [ Time Frame: 3 months ] [ Designated as safety issue: No ]
  • Incidence of herpes zoster [ Time Frame: 3 months ] [ Designated as safety issue: No ]
  • Chronic lymphocytic leukemia disease activity [ Time Frame: 3 months ] [ Designated as safety issue: No ]
  • Incidence and type of ARI in untreated cohort [ Time Frame: 3 months ] [ Designated as safety issue: No ]
  • Incidence of confirmed influenza and respiratory syncytial virus by a physician [ Time Frame: 3 months ] [ Designated as safety issue: No ]

Enrollment: 293
Study Start Date: September 2008
Study Completion Date: June 2009
Primary Completion Date: December 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Arm I
Patients receive oral American ginseng extract twice daily.
Dietary Supplement: American ginseng
Given orally
Placebo Comparator: Arm II
Patients receive oral placebo twice daily.
Dietary Supplement: placebo
Given orally

Detailed Description:

OBJECTIVES:

Primary

  • To assess the effect of American ginseng extract on the number of days of acute respiratory infection (ARI) during the peak respiratory illness season (January-March) in patients with chronic lymphocytic leukemia (CLL).
  • To determine the safety of American ginseng extract in these patients evaluated according to NCI CTCAE v3.0.

Secondary

  • To assess the effect of this treatment on antibiotic use days (AUDs).
  • To assess the effect of this treatment on the rate of all infections diagnosed by a physician.
  • To assess the effect of this treatment on the duration and severity of each ARI episode.
  • To assess the effect of this treatment on major infections defined as infection severe enough to require hospitalization or intravenous antibiotics.
  • To assess the effect of this treatment on the incidence of herpes zoster infection defined as an episode of physician-diagnosed zoster infection.
  • To assess the effect of this treatment on CLL disease activity (i.e., serum IgG, total lymphocyte count, platelet count, and Rai staging).
  • To determine the incidence of ARI and type of illness in an untreated cohort of CLL patients over an entire winter respiratory illness season (January 1- April 30).

Tertiary

  • To determine the effect of this treatment on the incidence of influenza and respiratory syncytial virus confirmed by a physician.

OUTLINE: This is a multicenter study. Patients are stratified according to antibiotic prophylaxis with trimethoprim-sulfamethoxazole (yes vs no), serum IgG (≤ 500 mg/dL vs > 500 mg/dL), and influenza vaccine status (yes vs no). Patients are randomized to 1 of 2 treatment arms.

  • Arm I: Patients receive oral American ginseng extract twice daily.
  • Arm II: Patients receive oral placebo twice daily. Treatment in both arms continues for up to 4 months in the absence of illness or adverse events.

After completion of study treatment, patients are followed at 4 weeks by phone.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS:

  • Diagnosis of chronic lymphocytic leukemia (CLL)

    • Phenotypic evidence (i.e., flow cytometry or bone marrow biopsy) of disease
  • Untreated CLL allowed

PATIENT CHARACTERISTICS:

  • ECOG performance status (PS) 0-2 OR Karnofsky PS 60-100%
  • Life expectancy > 12 months
  • Creatinine < 2.0 mg/dL OR creatinine clearance > 50 mL/min
  • AST/ALT ≤ 2.5 times upper limit of normal (ULN)
  • Total bilirubin ≤ 1.5 times ULN
  • Not pregnant or nursing
  • Fertile patients must use effective contraception prior to and during study treatment
  • No known cirrhosis, collagen vascular disease, multiple sclerosis, or HIV positivity
  • No other prior or concurrent malignancies except for non-melanoma skin cancers or carcinoma in situ of the cervix

    • Other prior malignancies allowed provided the patient has been disease-free for > 5 years
  • No uncontrolled intercurrent illness including, but not limited to, any of the following:

    • Ongoing or active infection
    • Symptomatic congestive heart failure
    • Unstable angina pectoris
    • Cardiac arrhythmia
  • No psychiatric or social illness that would limit compliance with study requirements
  • No history of allergy or other adverse response to ginseng products
  • No history of seasonal or environmental allergies that require ongoing treatment with antihistamines, intranasal corticosteroids, or systemic corticosteroids

PRIOR CONCURRENT THERAPY:

  • More than 3 months since prior and no concurrent chlorambucil
  • At least 1 month since prior and no other concurrent herbal ginseng products
  • No prior or concurrent fludarabine, alemtuzumab, rituximab, intravenous immunoglobulin, or hematopoietic stem cell transplantation
  • No concurrent corticosteroids (20 mg/day of prednisone or equivalent)
  • No concurrent antibiotic prophylaxis, except for trimethoprim-sulfamethoxazole
  • No concurrent warfarin
  • No other concurrent investigational or commercial agents or other therapies with the intent to treat the patient's malignancy
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00752895

  Show 125 Study Locations
Sponsors and Collaborators
Wake Forest Cancer Center CCOP Research Base
Investigators
Principal Investigator: Kevin High, MD Comprehensive Cancer Center of Wake Forest University
  More Information

Additional Information:
No publications provided

Responsible Party: Wake Forest Cancer Center CCOP Research Base
ClinicalTrials.gov Identifier: NCT00752895     History of Changes
Other Study ID Numbers: CCCWFU98308, U10CA081851
Study First Received: September 13, 2008
Last Updated: April 3, 2013
Health Authority: United States: Federal Government

Keywords provided by Wake Forest Cancer Center CCOP Research Base:
stage I chronic lymphocytic leukemia
stage II chronic lymphocytic leukemia
stage III chronic lymphocytic leukemia
stage IV chronic lymphocytic leukemia

Additional relevant MeSH terms:
Leukemia
Leukemia, Lymphocytic, Chronic, B-Cell
Leukemia, Lymphoid
Respiratory Tract Infections
Neoplasms by Histologic Type
Neoplasms
Leukemia, B-Cell
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Infection
Respiratory Tract Diseases
Anti-Bacterial Agents
Antibiotics, Antitubercular
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Antitubercular Agents

ClinicalTrials.gov processed this record on August 26, 2014